S.I.F.A. II: Prevention Of Thromboembolic Events In Patients With Nonrheumatic Atrial Fibrillation

NCT ID: NCT00244426

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1372 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-12-31

Study Completion Date

2008-04-30

Brief Summary

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Evaluate efficacy and safety of Indobufen v. Aspirin in preventing thromboembolic events in patients at high risk of CV events such as patients suffering from nonrheumatic atrial fibrillation.

Detailed Description

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Conditions

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Atrial Fibrillation

Keywords

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Prevention of thromboembolic events in patients with non valvular atrial fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

indobufen

Intervention Type DRUG

Indobufen capsules 100 and 200mg

2

Group Type ACTIVE_COMPARATOR

aspirin

Intervention Type DRUG

Acetylsalicylic acid capsules 300mg

Interventions

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indobufen

Indobufen capsules 100 and 200mg

Intervention Type DRUG

aspirin

Acetylsalicylic acid capsules 300mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Chronic or paroxysmal non rheumatic atrial fibrillation with cardioembolic risk factors: hypertension, ischemic cardiopathy, Congestive Heart Failure, diabetes mellitus

Exclusion Criteria

* Clinically relevant organ disease
* creatinine clearance \< 30 ml/min
* gastric or duodenal ulcer
* severe anaemia or poliglobulia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Lagosanto, FE, Italy

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Perugia, PG, Italy

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Perugia, PG, Italy

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Poggibonsi, SI, Italy

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Siena, SI, Italy

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Busto Arsizio, VA, Italy

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Peschiera del Garda, VR, Italy

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Abbadia S. Salvatore (SI), , Italy

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Acquaviva Delle Fonti (BA), , Italy

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Albano Laziale, , Italy

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Alessandria, , Italy

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Ancona, , Italy

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Ancona, , Italy

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Angera, , Italy

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Antella, , Italy

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Aosta, , Italy

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Arezzo, , Italy

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Assisi, , Italy

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Asti, , Italy

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Avellino, , Italy

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Bari, , Italy

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Bari, , Italy

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Bentivoglio, , Italy

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Bergamo, , Italy

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Bologna, , Italy

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Bologna, , Italy

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Bologna, , Italy

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Brindisi, , Italy

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Cagliari, , Italy

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Carbonia, , Italy

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Casarano, , Italy

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Casarano (LE), , Italy

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Caserta, , Italy

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Cassano Delle Murge (BA), , Italy

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Castelfranco Veneto, , Italy

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Castiglion Del Lago, , Italy

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Catania, , Italy

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Catania, , Italy

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Catania, , Italy

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Catania, , Italy

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Catanzaro, , Italy

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Cesena, , Italy

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Chieti, , Italy

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Cirie (TO), , Italy

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Citta' Di Castello (Pg), , Italy

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Cittadella, , Italy

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Città della Pieve, , Italy

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Copertino, , Italy

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Cosenza, , Italy

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Cremona, , Italy

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Cuneo, , Italy

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Desio, , Italy

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Eboli (SA), , Italy

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Faenza, , Italy

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Fidenza, , Italy

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Florence, , Italy

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Florence, , Italy

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Florence, , Italy

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Foggia, , Italy

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Foligno, , Italy

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Forlimpopoli (Fo), , Italy

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Forlì, , Italy

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Frosinone, , Italy

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Genova, , Italy

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Genova, , Italy

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Giulianova, , Italy

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Gorizia, , Italy

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Gracciano (Si), , Italy

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Grosseto, , Italy

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Gubbio, , Italy

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Gubbio (PG), , Italy

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Imperia, , Italy

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Latina, , Italy

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Lecce, , Italy

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Livorno, , Italy

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Lucca, , Italy

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L’Aquila, , Italy

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Macerata, , Italy

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Mantova, , Italy

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Martina Franca, , Italy

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Matera, , Italy

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Messina, , Italy

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Mestre, , Italy

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Milan, , Italy

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Milan, , Italy

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Moncalieri to, , Italy

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Napoli, , Italy

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Orvieto Scalo, , Italy

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Padua, , Italy

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Palermo, , Italy

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Pavia, , Italy

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Pescara, , Italy

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Piombino, , Italy

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Pisa, , Italy

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Pistoia, , Italy

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Popoli (Pe), , Italy

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Potenza, , Italy

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Pozzilli, , Italy

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Prato, , Italy

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Ravenna, , Italy

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Reggio Emilia, , Italy

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Rho (MI), , Italy

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Rimini, , Italy

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Roma, , Italy

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Roma, , Italy

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Roma, , Italy

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Roma, , Italy

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S. Giovanni Rotondo, , Italy

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San Bonifacio, , Italy

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San Felice A Cancello, , Italy

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San Giovanni Rotondo, , Italy

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San Vito al Tagliamento, , Italy

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Sant' Omero ( Te), , Italy

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Sassari, , Italy

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Savigliano, , Italy

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Siena, , Italy

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Taranto, , Italy

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Telese Terme, , Italy

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Termoli, , Italy

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Todi, , Italy

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Torino, , Italy

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Torino, , Italy

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Torino, , Italy

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Torre Del Greco (NA), , Italy

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Trieste, , Italy

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Udine, , Italy

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Varese, , Italy

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Velletri, , Italy

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Vibo Valentia, , Italy

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Vicenza, , Italy

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Vigevano, , Italy

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Viterbo, , Italy

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Countries

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Italy

Related Links

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Other Identifiers

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A7651004

Identifier Type: -

Identifier Source: secondary_id

293-CVD-9010-004

Identifier Type: -

Identifier Source: org_study_id